Abstract
The demands of designing safe and effective medical devices have significantly increased for the past decades. For example, Long [4] expressed a demand of improving current orthopedic medical devices by illustrating and discussing the uses, general properties, and limitations of orthopedic biomaterials. The emergence of fraudulent devices drove the need for regulations [5]. Countries all over the world have established their laws and regulations to systematically manage the medical devices in their respective markets. In the United States, for example, to assure the safety and effectiveness of medical devices in its market, the FDA (Food and Drug Administration) has established three regulatory classes based on the level of control: Class I General Controls (with or without exemptions), Class II General Controls and Special Controls (with or without exemptions), and Class III General Controls and Premarket Approval. For Class I and some Class II devices, simple controls will suffice for FDA clearance. Class III medical devices are subject to quality system requirements and stringent adverse event reporting and post-market surveillance [6]. For companies that produce Class III medical devices, a premarket approval (PMA) will be required before the devices can be marketed. This is because the risk to the user or patient determines that a mass of trials have to be done before approval [7]. All device manufacturing facilities are expected to be inspected every two years.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Similar content being viewed by others
References
Zeng, Y., Environment-Based Design (EBD), The 2011 ASME International Design Engineering Technical Conferences (IDETC) and Computers and Information in Engineering Conference (CIE), Washington, DC, August 28–31, 2011, DETC2011–48263.
Chen, M., Z. Chen, L. Kong, and Y. Zeng, Analysis of medical devices design requirements. J. Integr. Des. Process Sci., 2005. 9(4): p. 61–70.
Chen, Z.Y. and Y. Zeng, Classification of product requirements based on product environment. Concurrent Engineering, 2006. 14(3): p. 219–230.
Long, P.H., Medical devices in orthopedic applications. Toxicologic Pathology, 2008. 36(1): p. 85–91.
Rados, C. Medical device and radiological health regulations come of age. 2006 [cited Nov. 2010]; The Centennial Edition Available from: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/MedicalDeviceandRadiologicalHealthRegulationsComeofAge/default.htm.
Pisano, D.J. and D.S. Mantus, eds. Fda regulatory affairs: A guide for prescription drugs, medical devices, and biologics. 2rd ed. 2008, Informa Healthcare: New York. 464.
Schuh, J.C.L., Medical device regulations and testing for toxicologic pathologists. Toxicologic Pathology, 2008. 36(1): p. 63–69.
Kohn, L.T., J.M. Corrigan, and M.S. Donaldson, eds. To err is human: Building a safer health system. 1 ed. 1999, National Academies Press: Washington, D.C. 287.
Altman, D.E., C. Clancy, and R.J. Blendon, Improving patient safety – five years after the iom report. New England Journal of Medicine, 2004. 351(20): p. 2041–2043.
Rousselle, S. and J. Wicks, Preparation of medical devices for evaluation. Toxicologic Pathology, 2008. 36(1): p. 81–84.
CDRH. Medical device use-safety: Incorporating human factors engineering into risk management. 2000 [cited Nov. 2010]; Available from: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094461.pdf.
FDA. Why is human factors engineering important for medical devices. 2001 [cited Nov. 2010.
Lin, L., K.J. Vicente, and D.J. Doyle, Patient safety, potential adse drug events, and medical device design: A human factors engineering approach. Comput. Biomed. Res., 2001.ver 34(4): p. 274–284.
Gosbee, Human factors engineering and patient safety. Qual. Saf. Health Care, 2002. 11(4): p. 352–354.
Malhotra, S., A. Laxmisan, A. Keselman, J. Zhang, and V.L. Patel, Designing the design phase of critical care devices: A cognitive approach. J. of Biomedical Informatics, 2005. 38(1): p. 34–50.
Ginsburg, G., Human factors engineering: A tool for medical device evaluation in hospital procurement decision-making. J. of Biomedical Informatics, 2005. 38(3): p. 213–219.
Martin, J.L., B.J. Norris, E. Murphy, and J.A. Crowe, Medical device development: The challenge for ergonomics. Applied Ergonomics, 2008. 39(3): p. 271–283.
Fairbanks, R.J. and R.L. Wears, Hazards with medical devices: The role of design. Annals of emergency medicine, 2008. 52(5): p. 519–521.
Kools, M., M.W.J. van de Wiel, R.A.C. Ruiter, and G. Kok, Pictures and text in instructions for medical devices: Effects on recall and actual performance. Patient education and counseling, 2006. 64(1): p. 104–111.
Berman, A., Reducing medication errors through naming, labeling, and packaging. J. Med. Syst., 2004. 28(1): p. 9–29.
Zeng, Y., Environment-based formulation of design problem. J. Integr. Des. Process Sci., 2004. 8(4): p. 45–63.
Zeng, Y. and G.D. Cheng, On the logic of design. Design Study, 1991. 12(3): p. 137–141.
Zeng, Y., Axiomatic theory of design modeling. J. Integr. Des. Process Sci., 2002. 6(3): p. 1–28.
Zeng, Y., Recursive object model (ROM)-modelling of linguistic information in engineering design. Comput. Ind., 2008. 59(6): p. 612–625.
Wang, M. and Y. Zeng, Asking the right questions to elicit product requirements. Int. J. Comput. Integr. Manuf., 2009. 22(4): p. 283–298.
Acknowledgements
This work is partially supported by NSERC through its Discovery Grant program (Grant number RGPIN 298255).
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2011 Springer Science+Business Media, LLC
About this paper
Cite this paper
Tan, S., Zeng, Y., Montazami, A. (2011). MEDICAL DEVICES DESIGN BASED ON EBD: A CASE STUDY. In: Suh, S., Gurupur, V., Tanik, M. (eds) Biomedical Engineering. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-0116-2_1
Download citation
DOI: https://doi.org/10.1007/978-1-4614-0116-2_1
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-0115-5
Online ISBN: 978-1-4614-0116-2
eBook Packages: Computer ScienceComputer Science (R0)